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Effect of Reduced Corticosteroids on Premature Birth

Randomized controlled study of improving preterm birth outcomes by reducing prenatal corticosteroid exposure

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500096518
Enrollment
Unknown
Registered
2025-01-24
Start date
2025-02-01
Completion date
Unknown
Last updated
2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

preterm birth

Interventions

Comparison group 2:Low-dose dexamethasone use
control group:Conventional high-dose dexamethasone use
Comparison group 1:Low-dose betamethasone sodium phosphate use

Sponsors

Chongqing Health Center for Women and Children
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1 Pregnant women being able to sign informed consent; 2 single, twin or multiple pregnancies; 3 28+0-34+6 gestational weeks; 4 Pregnant women clinically assessed to be at high risk of imminent delivery (i.e., within 1 to 14 days after the start of treatment). High risk of delivery is defined as: 1 The. length of the cervix is at least 3cm, with contraction and unbroken amniotic membrane; 2. premature rupture of membranes; 3. Preterm birth is expected within 1 to 14 days of planned randomization due to any other indication (mode of delivery is determined by the obstetrician).

Exclusion criteria

Exclusion criteria: 1? The pregnant women will be excluded, if delivery is expected to be less than 24 hours or more than 14 days later; 2? Intrauterine death; 3?The presence of fetal distress requiring immediate termination of pregnancy; 4? Major fetal structural or genetic abnormalities; 5? Corticosteriods contraindications; 6? Prenatal corticosteriods was used during this pregnancy; 7? The amniotic membrane is broken with regular contractions (at least once every 5 minutes) and the uterine opening larger than 3 cm; 8? Uterine opening 8cm or more; 9? No accurate due date.

Design outcomes

Primary

MeasureTime frame
The number of stillbirths/newborns who were treated with surfactants at any time within 72 hours of birth and/or perinatal deaths (prenatal stillbirths or deaths within 7 days of birth);The number of newborns who completed the entire treatment and delivered within 1 to 14 days after the start of treatment;

Secondary

MeasureTime frame
Physical and Biochemical index;

Countries

China

Contacts

Public ContactHongbo Qi

Chongqing Health Center for Women and Children

qihongbo728@163.com+86 23 63809721

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026